Trial Outcomes & Findings for Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer (NCT NCT03056638)
NCT ID: NCT03056638
Last Updated: 2024-08-28
Results Overview
compare 2-year biopsy positivity rate of intermediate risk prostate cancer patients treated with SBRT + short course ADT versus SBRT alone.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
56 participants
Primary outcome timeframe
2 years
Results posted on
2024-08-28
Participant Flow
Participant milestones
| Measure |
Degarelix in Conjunction With Stereotactic Body Radiosurgery
Degarelix monthly for 6 months SBRT 8 Gy x 5
Degarelix: Degarelix monthly for 6 months
stereotactic body radiosurgery (SBRT): SBRT 8 Gy x 5
|
Stereotactic Body Radiosurgery (SBRT)
SBRT 8 Gy x 5
stereotactic body radiosurgery (SBRT): SBRT 8 Gy x 5
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
29
|
|
Overall Study
COMPLETED
|
26
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Degarelix in Conjunction With Stereotactic Body Radiosurgery
Degarelix monthly for 6 months SBRT 8 Gy x 5
Degarelix: Degarelix monthly for 6 months
stereotactic body radiosurgery (SBRT): SBRT 8 Gy x 5
|
Stereotactic Body Radiosurgery (SBRT)
SBRT 8 Gy x 5
stereotactic body radiosurgery (SBRT): SBRT 8 Gy x 5
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
Baseline Characteristics
Trial of ADT and SBRT Versus SBRT for Intermediate Prostate Cancer
Baseline characteristics by cohort
| Measure |
Degarelix in Conjunction With Stereotactic Body Radiosurgery
n=27 Participants
Degarelix monthly for 6 months SBRT 8 Gy x 5
Degarelix: Degarelix monthly for 6 months
stereotactic body radiosurgery (SBRT): SBRT 8 Gy x 5
|
Stereotactic Body Radiosurgery (SBRT)
n=29 Participants
SBRT 8 Gy x 5
stereotactic body radiosurgery (SBRT): SBRT 8 Gy x 5
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
70 years
n=7 Participants
|
68 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: N/A - data were not collected
compare 2-year biopsy positivity rate of intermediate risk prostate cancer patients treated with SBRT + short course ADT versus SBRT alone.
Outcome measures
Outcome data not reported
Adverse Events
Degarelix in Conjunction With Stereotactic Body Radiosurgery
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Stereotactic Body Radiosurgery (SBRT)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Degarelix in Conjunction With Stereotactic Body Radiosurgery
n=27 participants at risk
Degarelix monthly for 6 months SBRT 8 Gy x 5
Degarelix: Degarelix monthly for 6 months
stereotactic body radiosurgery (SBRT): SBRT 8 Gy x 5
|
Stereotactic Body Radiosurgery (SBRT)
n=29 participants at risk
SBRT 8 Gy x 5
stereotactic body radiosurgery (SBRT): SBRT 8 Gy x 5
|
|---|---|---|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
3.7%
1/27 • 1 year
|
0.00%
0/29 • 1 year
|
Other adverse events
| Measure |
Degarelix in Conjunction With Stereotactic Body Radiosurgery
n=27 participants at risk
Degarelix monthly for 6 months SBRT 8 Gy x 5
Degarelix: Degarelix monthly for 6 months
stereotactic body radiosurgery (SBRT): SBRT 8 Gy x 5
|
Stereotactic Body Radiosurgery (SBRT)
n=29 participants at risk
SBRT 8 Gy x 5
stereotactic body radiosurgery (SBRT): SBRT 8 Gy x 5
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
3.7%
1/27 • 1 year
|
0.00%
0/29 • 1 year
|
|
Investigations
Lymphocyte count decreased
|
3.7%
1/27 • 1 year
|
0.00%
0/29 • 1 year
|
Additional Information
Dr. Michael Zelefsky, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-6802
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place